FDA 510(k) Application Details - K210793

Device Classification Name	More FDA Info for this Device
510(K) Number	K210793
Device Name	VIDAS NEPHROCHECK
Applicant	bioMΘrieux SA 376 Chemin de lÆOrme Marcy lÆEtoile 69280 FR Other 510(k) Applications for this Company
Contact	Julien Thao My Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2021
Decision Date	07/08/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review